IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I is an FDA 510(k)-cleared medical device (K843930) manufactured by Euro-Diagnostics BV. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 29, 1984. Regulation: 8.